Titre |
A Phase I-II Open-label Study of Non-myeloablative-allogeneic Transplant of ECT-001 (UM171/ Fed-batch Culture System) Expanded Cord Blood in Patients With High-risk Multiple Myeloma |
Protocole ID |
ECT001-003 |
ClinicalTrials.gov ID |
NCT03441958 |
Type(s) de cancer |
Myélome |
Phase |
Phase I-II |
Stade |
Myélome multiple |
Type étude |
Traitement |
Institution |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
5415 boul. de l'Assomption, Montréal, QC, H1T2M4
|
Ville |
Montréal |
Investigateur(trice) principal(e) |
Dr Jean Roy
|
Coordonnateur(trice) |
Séverine Landais
514-252-3400 poste 3609
|
Statut |
Fermé |
Critètes d'éligibilité |
- Age 18-65 years.
-
Newly diagnosed multiple myeloma using the International Myeloma Working Group criteria with measurable disease and any of the following:
i. t(4;14), t(14;16), t(14;20), del(17p13), chromosome 1 abnormalities with ISS II or III; ii. Revised-ISS 3; iii. Primary plasma cell leukemia; iv. Refractory to first line triplet Bortezomib-based induction treatment. v. ≥ 2 cytogenetics abnormalities as defined above regardless of ISS stage
- Received a first line triplet Bortezomib-induction regimen for a minimum of 4 cycles with achievement of at least partial response; or received a doublet or triplet Lenalidomide-based second line induction treatment with at least partial response for patients refractory to Bortezomib in first line.
- Received high-dose Melphalan ≥ 140 mg/m2 followed by ASCT.
- Availability of a cord blood with an HLA match ≥ 5/8 and < 8/8 meeting the following requirements: CD34+ cell count ≥ 0.5 x 105/kg and nucleated cell count >= 1.5 x 107/kg.
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Critètes d'exclusion |
- Having previously received two ASCT.
- Having previously received autologous-allogeneic tandem transplantation.
- Having received more than 4 months of maintenance with Lenalidomide or Bortezomib after ASCT.
- Poor organ function defined as either: forced vital capacity, forced expiratory volume in 1 second or lung diffusing capacity of carbon monoxide corrected for hemoglobin < 50%, left ventricular ejection fraction < 40% (evaluated by either echocardiogram or MUGA), uncontrolled arrhythmia or symptomatic cardiac disease, creatinine clearance < 60 mL/minute.
- Karnofsky score < 70% or comorbidity index HCT-CI > 3.
- Bilirubin > 2 x upper limit of normal (ULN) unless felt to be related to Gilbert's disease or hemolysis; AST and ALT > 2.5 x ULN; alkaline phosphatase > 5 x ULN; liver cirrhosis.
- Non secretory disease or non-measurable disease in serum or urine at time of diagnosis.
- Uncontrolled infection.
- Active infection with any of the following viruses: HIV, HTLV-1 or 2, hepatitis B or C.
- Presence of another malignancy with an expected survival estimated < 75% at 5 years.
- Suspicion of cardiac amyloidosis.
- Current history of drug and/or alcohol abuse.
- Availability of a matched sibling donor.
- Pregnancy, breastfeeding or unwillingness to use appropriate contraception.
- Participation in a trial with an investigational agent within 30 days prior to entry in the study.
- Patient unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up and tests.
- Any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient's condition or study outcome.
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